MIRA-4: Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects

Sponsor

Ocuphire Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05223478

Collaborator

(none)

Enrollment

Locations

Arms

4.3

Actual Duration (Months)

11.5

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are:

To evaluate the safety of Nyxol in pediatric subjects
To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."

Condition or Disease	Intervention/Treatment	Phase
Mydriasis Dilation	Drug: Phentolamine Ophthalmic Solution 0.75% Drug: Phentolamine Ophthalmic Solution Vehicle	Phase 3

Detailed Description

This is a randomized, parallel-arm, double-masked, placebo-controlled study in approximately 20 randomized pediatric subjects evaluating the safety and efficacy of Nyxol in pediatric subjects with pharmacologically induced mydriasis with three dilating agents (e.g., phenylephrine, tropicamide, and Paremyd). Pediatric subjects will be recruited for the study into 2 age groups as follows:1) 3 to 5 years of age: 10 subjects 2) 6 to 11 years of age: 10 subjects.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically Induced Mydriasis in Healthy Pediatric Subjects

Actual Study Start Date :

Dec 17, 2021

Actual Primary Completion Date :

Apr 18, 2022

Actual Study Completion Date :

Apr 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phentolamine Ophthalmic Solution 0.75% One drop of study medication in each eye.	Drug: Phentolamine Ophthalmic Solution 0.75% 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist Other Names: Nyxol® Nyxol
Placebo Comparator: Phentolamine Ophthalmic Solution Vehicle One drop of study medication in each eye.	Drug: Phentolamine Ophthalmic Solution Vehicle Phentolamine Ophthalmic Solution Vehicle

Arm

Intervention/Treatment

Active Comparator: Phentolamine Ophthalmic Solution 0.75%

One drop of study medication in each eye.

Drug: Phentolamine Ophthalmic Solution 0.75%

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Other Names:

Nyxol®

Nyxol

Placebo Comparator: Phentolamine Ophthalmic Solution Vehicle

One drop of study medication in each eye.

Drug: Phentolamine Ophthalmic Solution Vehicle

Phentolamine Ophthalmic Solution Vehicle

Outcome Measures

Primary Outcome Measures

Safety Measurements [0 Minutes]
Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 4, with 4 being considered the most severe.
Safety Measurements [90 Minutes]
Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 4, with 4 being considered the most severe.
Safety Measurements [3 Hours]
Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 4, with 4 being considered the most severe.
Safety Measurements [24 Hours]
Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 4, with 4 being considered the most severe.
Vital Signs [3 Hours]
Change from Screening Heart Rate
Vital Signs [3 Hours]
Change from Screening Blood Pressure
Vital Signs [24 Hours]
Change from Screening Heart Rate
Vital Signs [24 Hours]
Change from Screening Blood Pressure
Safety Measurement [0 Minutes]
Change from Baseline (-1 Hour) Best Corrected Distance Visual Acuity
Safety Measurement [3 Hours]
Change from Baseline (-1 Hour) Best Corrected Distance Visual Acuity
Safety Measurement [24 Hours]
Change from Baseline (-1 Hour) Best Corrected Distance Visual Acuity

Secondary Outcome Measures

Efficacy Measurement: Pupil Diameter [0 Minutes, 90 Minutes, 3 Hours, and 24 Hours]
Percentage of Subjects Returning to ≤ 0.2 mm from Baseline (-1 hour) Pupil Diameter
Efficacy Measurement: Pupil Diameter [90 Minutes, 3 Hours, and 24 Hours]
Change (in mm) in Pupil Diameter from Max Pupil Dilation (0 minutes)
Efficacy Measurement: Pupil Diameter [Up to 24 Hours]
Time (Hours) to Return to ≤ 0.2 mm from Baseline (-1 Hour) Pupil Diameter (Time-savings Analysis)

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males or premenstrual females 3 to 11 years of age
Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
Parent/Legal guardian willing to give written informed consent to participate in this study. Children aged 7 to 11 years to provide signed assent form, as well as a separate parental/legal guardian consent.

Exclusion Criteria:

Clinically significant ocular disease as deemed by the Investigator(eg, amblyopia, congenital cataract, congenital glaucoma) that might interfere with the study
Unwilling or unable to discontinue use of contact lenses at screening until study completion
Unwilling or unable to suspend use of topical medication at screening until study completion
Ocular trauma or ocular surgery within the 6 months prior to screening
Use of any topical prescription or over-the-counter (OTC)ophthalmic medications of any kind within 7 days of screening
Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
Known allergy, hypersensitivity, or contraindication to any component of the phentolamine ophthalmic solution or to any component of the mydriatic agents or vehicle formulation

Systemic:

Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
Clinically significant systemic disease (eg, uncontrolled diabetes, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that in the opinion of the Investigator could interfere with the study
Subjects with learning disabilities that in the opinion of the investigator could interfere with the study
Initiation of treatment with or any changes to the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening or during the study(Appendix 4)
Participation in any investigational study within 30 days prior to screening